A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Ceftriaxone; Metronidazole

Criteria

Inclusion Criteria:

• 16 years of age or older.

• Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.

• Can be obtained a specimen for bacteriological efficacy assessment.

Exclusion Criteria:

• Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole, Ceftriaxone sodium, or other cephem antibiotics.

• Severe renal dysfunction (creatinine clearance < 30 mL/min.) Reference:

Cockcroft-Gault calculation formula.

• Hepatic dysfunction (AST, ALT, total bilirubin > 3 times upper limit of normal range values).

• Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.